GlaxoSmithKline announced late yesterday afternoon that it will acquire Sirtris Pharmaceuticals, the Massachusetts start-up company developing an analog of resveratrol, the chemical in red wine thought to promote longevity by postponing degenerative diseases. To prove this to the Food and Drug Administration's satisfaction, clinical trials involving thousands of people, perhaps even tens of thousands of people, stretching over many years, will have to take place.
Of course, the FDA could abandon its traditional standard and allow Glaxo to market a resveratrol analog as a pricey prescription drug based on lesser studies, which would make it the equivalent of dietary supplement. Since supplements do not have to meet the FDA's scientific standards of efficacy, there are already numerous resveratrol pills on the market. Check out this comment on the Wall Street Journal's Health blog:
According to Wikipedia, Consumer Lab, an independent dietary supplement and over the counter products evaluation organization, published a report on 13 November 2007 on the popular resveratrol supplements. The organization reported that there exists a wide range in quality, dose, and price among the 13 resveratrol products evaluated. The actual amount of resveratrol contained in the different brands range from 2.2mg for Revatrol, which claimed to have 400mg of “Red Wine Grape Complex”, to 500mg for Biotivia.com Transmax, which is consistent with the amount claimed on the product’s label. Prices per 100mg of resveratrol ranged from less than $.30 for products made by Biotivia.com, jarrow, and country life, to a high of $45.27 for the Revatrol brand. None of the products tested were found to have significant levels of heavy metals or other contaminants.
So why would anyone buy this drug? The Glaxo "drug" will be chemically manipulated to be much more potent and more easily absorbed than the natural substance. Is that worth $100 or more a month, the typical price of prescription drugs?
Drug companies are already well down the road to selling drugs that influence biomarkers of disease. LDL cholesterol isn't a disease, but lowering its high concentration in people already at risk of coronary artery disease lowers the incidence of heart attacks and strokes in that population. High blood pressure isn't a disease, but numerous studies have shown that reducing blood pressure correlates with fewer heart attacks and strokes.
Now they're moving into substances that, in their natural form, are good for you. Frankly, I'd rather have a daily glass of red wine. And for $100 a month, I can probably afford better wine than I'm drinking now.
You've got this completely wrong.
Resveratrol is not what the big bucks are being paid for, its the patents associated with their proprietary molecules related to the SIRT proteins. Resveratrol is really a precursor drug to demonstrate that the SIRT pathway has clinical efficacy. While it may end up being a drug, it likely will stop development when the next generation molecules enter Phase 2 this year.
Posted by: Anonymous at April 23, 2008 10:04 PMClinical efficacy against what? Ultimately, any proprietary molecule has to be aimed at a validated biomarker involved with diabetes (the first target disease for this class). And if they have that biomarker (I admit I have not followed this literature closely, but if blocking or promoting the SIRT pathway directly lowered blood sugar, I think we would have heard about it), won't proving the drug's usefulness ultimately require massive clinical trials to show that affecting that biomarker has an impact on the prevalence of diabetes or its progression? This is about preventing a disease (an inherently long-term proposition). I may be missing something, but I still don't see where this is any different than a dietary supplement, even if it is a proprietary molecule.
Posted by: Merrill at April 24, 2008 08:03 AMYou're mixing up a lot of things.
HbA1c is the biomarker for diabetes being used in the trials. SIRT isn't a biomarker of diabetes, its an enzyme class that they believe can improve diabetes, i.e. lower HbA1c.
They have several different potential drugs that targets the SIRT pathway. Resveratrol is one of them. That's the "nutritional" supplement. All of the others were developed by Sirtris, have nothing to do with resveratrol, but instead do a much better job at activating SIRT enzymes. GSK isn't buying them for resveratrol. They are buying them for all of the other molecules they have developed.
"I admit I have not followed this literature closely, but if blocking or promoting the SIRT pathway directly lowered blood sugar, I think we would have heard about it..."
Then follow the literature next time. They came out with data demonstrating they can lower HbA1c within the last few months. That's why the GSK deal happened now.
Posted by: Anonymous at April 26, 2008 05:13 PM